The present invention relates to determining when a product or medication has been distributed or dispensed properly. This is done in part by associating a unique code with each product or medication container, registering information about the product or medication and the code in a database, and subsequently using the code to retrieve the information about the product or medication. The invention also relates to enabling a healthcare worker or patient to verify that a medication has been properly distributed and dispensed.
As an initial matter, in the interest of simplifying this explanation and unless indicated otherwise, the description which follows describes the invention in the context of a medication manufacturer, medication distributor, pharmacy and patient home. However, it should be recognized that the invention should not be so limited and clearly has applications which are outside medication, only some of which are specifically discussed hereinafter.
Many industries have been plagued by fraudulent products being introduced into the market. Examples of this include the clothing of fashion designers, airplane maintenance parts, and recently, prescription and non-prescription medication. Fraudulent or mislabeled medications threaten the public's faith in the over $150 billion medication industry by misleading them to believe that a medication is what it says it is, for example the medication they are taking may actually be a sugar or flour pill with no ability to treat the patient's condition. In other cases a mislabeled medication can actually make a patient's condition worse or cause life threatening reactions.
To counteract this problem, a number of solutions have been proposed, each with a characteristic that attempts to deal with the problem, but none have created a reliable and easy to use system to prevent fraud, mislabeling, or redirection of medication in the supply and dispensing channels. For example, recently some pharmaceutical manufacturers have told their distributors that they will no longer ship products to them unless they agree only to purchase medications directly from the manufacturers. This directive potentially prevents fraudulent medication from entering the distribution channel by being traded from one distributor to another, but it already is unlikely that our country's quality medication distributors allow any fraudulent medication to enter their channel. It is also unlikely that large pharmacy chains that manage their own distribution centers would tolerate purchases from any source other than the original manufacturer. In fact many pharmacy chains purchase their own private labeled generic medication directly from qualified manufacturers, e.g. over the counter medications. In many cases fraudulent medication gets to a pharmacy via smaller or sub-distributors or by trading medication from one healthcare facility or pharmacy to another or by fraudulent substitution in the supply chain.
For years medication manufacturers have placed company or product logos on their packaging. These of course are easily copied by contemporary computer scanners and color printers. It has even been suggested that companies place on the Internet examples of the correct labeling and package appearance for their products and examples of fraudulent labels and packaging (when they have been detected). Needless to say busy pharmacists do not have the time to review a “Most Wanted Criminal” type posting for each fraudulent medication label or package on the Internet. Furthermore, this would only work for the most obvious of medication label or package defects. A system that ignores the threat posed by artfully reproduced labels and packages will only continue to expose the public to dangers, and potentially decrease safety by creating a false sense of security).
Another solution that has been proposed is to place holographic tags on medication containers, similar to those found on many credit cards. This creates an aura of protection it is largely illusionary. These proposals allow every pharmaceutical manufacturer to use whatever hologram design they choose. A pharmacist who wants to dispense a medication would have to be schooled in matching several hundred such tags manufacturers might use against the tag they see on a medication container they have selected. On top of this problem there are companies that will create imitation tags that to the casual observer might look legitimate, but aren't. In general, any solution that requires the healthcare worker to visually arbitrate the authenticity of a tag or special mark is unlikely to succeed. This is further compounded by the fact that pharmacists are in short supply and have no time for other activities beyond dispensing the growing number of prescriptions.
Other proposed solutions include placing special chemicals or markers on the labels or inks that are used to identify medication containers. The chemicals can be excited when exposed to certain light sources, e.g. ultraviolet light or a laser of a specific frequency, to reveal a hidden message or symbol. These solutions not only require more time of the pharmacist, but have the further problem of requiring the pharmacy to purchase special equipment to excite the chemicals.
Some solutions require testing the plastic or glass of a medication container by a laboratory to determine if minute amounts of chemical tags are present. Needless to say these are not solutions that offer immediate confirmation for the pharmacist.
All of the above solutions do not offer the distribution channel the opportunity to verify that medication they are handling is legitimate. For example a distributor of medication would have to open a box of medication to verify that each container within the box has been properly labeled with a tag, reactive chemical, or other special marking. One solution to overcome this concern has been to apply passive radio frequency identification tags (RFID) to each medication container. Such tags can be provided as read only tags (e.g. programmed by the silicon electronics manufacturer) or a single write tags/read many times or read/write multiple times (e.g. programmed by the pharmaceutical manufacturer) tags. These tags can generally be read through a box to determine what medication is in that box, which is better than the other proposed solutions.
One example of a RFID tag standard is the EPCglobal standard (see http://www.epcglobalinc.org/standards technology/specifications.html or EPC™ Tag Data Specification 1.0 for more information). Tags using this standard can be read by a wide variety of readers and are designed so as to identify a specific serial number (e.g. a container number) of a product made by a manufacturer. This is done by EPCglobal providing a table that converts a Domain manager number (a portion of the RFID tags contents) to a manufacturing company name. The company corresponding to the Domain Manager can then use other information in the RFID tag to determine the product name/type and a product serial number. RFID tags give the appearance of being harder to reproduce than logos or bar codes, although simple EPCglobal tags can be copied or emulated by adept electronic engineers. And therefore do not offer sufficient protection to prevent fraudulently labeled products from entering the distribution channel.
Furthermore, none of the medication container verification techniques allows the consumer to determine that the medication that has been dispensed to them corresponds to the medication that was supposed to be provided them, nor to determine the status of the medication (e.g. recall status, that the medication was originally shipped overseas, or that the bulk container used by the their pharmacy to dispense medication is registered in duplicate with one used to dispense medication in another state indicating that one of the bulk containers is fraudulent).
By way of comparison, another field that is concerned about verification of a “product” is the credit card business. In this case a credit card with an embossed number is prepared by a bank and is given to consumers. The consumer, when they purchase an item gives their credit card to the retailer for verification and transaction approval. While the credit card may have a picture of the consumer printed on it and/or a holographic picture placed on it, the retailer must verify the credit card number as well prior to proceeding with the transaction. The retailer does this by reading the credit card number (typically using a reader to read the magnetic strip on the rear of the card or by visually reading the numbers and manually typing them into a keypad) and then transferring (e.g. telephone line or dedicated network link) the credit card number, the amount of the purchase (and sometimes the item being purchased), and a retailer identification number to a credit card verification computer system. This system may be a single system (e.g. the one used by American Express) or a centralized system that refers to the member banks' computers to determine the account status (e.g. VISA or Master Card). The verification system checks the credit card number to determine that it has been issued to a consumer (elimination of fake numbers or numbers associated with a different credit card company), to determine the status of the account (has the consumer paid their bills or has the consumer reported the card stolen or lost), and to check that the retailer is registered with the credit card company (invalid retailers can be eliminated this way).
When the credit card verification computer system determines that all checks have been passed, an approval message is returned to the retailer and the purchase can be concluded by the consumer signing the credit card receipt. If the computer system determines that one or more of the checks fails (the purchase amount is greater than a limit, the account balance has not been recently paid, or the card reported lost) the transaction will not be concluded. If the credit card has been reported lost or stolen, the retailer may be requested to retain or quarantine the credit card.
The credit card verification process, while instructive, is not capable of dealing with the dispensing and tracking of medication. For example, the consumer is given a single credit card and number, which the consumer retains and guards, for multiple transactions. In the case of medication the consumer is provided with multiple medication containers over time, each of which should be separately and uniquely authenticated.
By way of further comparison, another field that is concerned about verification of a “product” is the software industry which has developed methods to verify that fraudulent copies of software are not registered or verified. One scheme has been to distribute software on CD-ROM disks with a unique registration code that is included with the labeling of the CD, e.g. printed on the CD jewel case folder or written directly on the CD label. The user installs the software on the CD onto their computer and is then requested to enter the registration code as part of the installation process. The user enters the code, which is verified by the installation software or is sent to a remote verification system. If the code is not verified as being a correct code the installation is terminated. If the code is sent in duplicate to a verification system the system will refuse to install the software unless it is being “re-installed” on same computer on which it was originally installed.
While instructive, this form of a product verification system has four weaknesses; one it requires that the person using the registration system perform a software installation before the authenticity of the software has been verified; two it allows anyone to attempt to enter and verify a registration code; third it does not provide the consumer with information that they can use to verify that the product is correct other than the response of the registration system that the registration code is correct or not; and lastly it does not provide for dispensing a portion of the software product with a new code that can be verified by the consumer.
None of the above solutions allow the patient or consumer to determine that medication that has been dispensed to them is authentic, as none of the medication container labeling schemes can be readily verified by the consumer. This is especially the case when medication is dispensed by transferring it from one container (e.g. a bulk bottle) to another container (e.g. a vial, blister, or packet).
Thus, it would be advantageous to have a medication labeling and verification system that can be used at any point of the distribution, dispensing, and consuming process. Such a system would need to be easy to deploy using existing technologies and use container labels that are easily detected when a fraudulent medication has attempted to be verified.